Wockhardt Famotodine Tablets Recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

A) Lot #: LM10708, Expiry: 4/30/2015; Lot #: LM10859, Expiry: 5/31/2015; Lot #: LM11200, Expiry: 7/31/2015; Lot #: LM11679, Expiry: 9/30/2015; Lot #: LN10465, Expiry: 1/31/2016; Lot #: LN10750, Expiry: 3/31/2016; Lot #: LN11385, Expiry: 9/30/2016. B) Lot #: LM10709, Expiry: 4/30/2015; Lot #: LM10719, Expiry: 4/30/2015; Lot #: LM10721, Expiry: 4/30/2015; Lot #: LM10827, Expiry: 5/31/2015; Lot #: LM10828, Expiry: 5/31/2015; Lot #: LM10912, Expiry: 5/31/2015, Lot #: LM11205, Expiry: 7/31/2015; Lot #: LM11206, Expiry: 7/31/2015, Lot #: LM11239. Expiry: 7/31/2015; Lot #: LM11680, Expiry: 9/30/2015; Lot #: LM11822, Expiry: 10/31/2015; Lot #: LM11993, Expiry: 10/31/2015; Lot #: LN10114, Expiry: 12/31/2015; Lot #: LN10115, Expiry: 12/31/2015; Lot #: LN10695, Expiry: 3/31/2016; Lot #: LN10696, Expiry: 3/31/2016; Lot #: LN10697, Expiry: 3/31/2016; Lot #: LN10745, Expiry: 3/31/2016; Lot #: LN10749, Expiry: 3/31/2016; Lot #: LN11249, Expiry: 6/30/2016; Lot #: LN11374, Expiry: 8/31/2016; Lot #: LN11376, Expiry: 8/31/2016; Lot #: LN11382, Expiry: 7/31/2016; Lot #: LN11386, Expiry: 9/30/2016. C) Lot #: LM10685, Expiry: 4/30/2015; Lot #: LM10687, Expiry: 4/30/2015; Lot #: LM10691, Expiry: 4/30/2015; Lot #: LM10692, Expiry: 4/30/2015; Lot #: LM10707, Expiry: 4/30/2015; Lot #: LM10735, Expiry: 4/30/2015; Lot #: LM10741, Expiry: 4/30/2015; Lot #: LM10743, Expiry: 4/30/2015; Lot #: LM10860, Expiry: 5/31/2015; Lot #: LM10861, Expiry: 5/31/2015; Lot #: LM10862, Expiry: 5/31/2015; Lot #: LM10869, Expiry: 5/31/2015; Lot #: LM10911, Expiry: 5/31/2015; Lot #: LM11158, Expiry: 4/30/2015; Lot #: LM12039, Expiry: 10/31/2015; Lot #: LN10426, Expiry: 1/31/2016; Lot #: LN10427, Expiry: 1/31/2016; Lot #: LN10428, Expiry: 1/31/2016; Lot #: LN10435, Expiry: 1/31/2016; Lot #: LN10463, Expiry: 1/31/2016; Lot #: LN10464, Expiry: 1/31/2016; Lot #: LN10674, Expiry: 3/31/2016; Lot #: LN10675, Expiry: 3/31/2016; Lot #: LN10676, Expiry: 3/31/2016; Lot #: LN10751, Expiry: 3/31/2016; Lot #: LN11017, Expiry: 5/31/2016; Lot #: LN11018, Expiry: 5/31/2016; Lot #: LN11023, Expiry: 5/31/2016; Lot #: LN11216, Expiry: 6/30/2016; Lot #: LN11217, Expiry: 6/30/2016; Lot #: LN11391, Expiry: 9/30/2016; Lot #: LN11394, Expiry: 9/30/2016; Lot #: LN11401, Expiry: 9/30/2016; Lot #: LN11408, Expiry: 9/30/2016; Lot #: LN11410, Expiry: 9/30/2016.

U.S. Nationwide including Puerto Rico.

• Compare the lot number and expiration date on your package with the codes above.
• Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
• If you have symptoms you think are related, contact your doctor. In an emergency call 911.
• Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall number

D-1265-2015

Classification

Class II

Status

Terminated

Recall initiated

Apr 22, 2015

FDA report date

Jul 29, 2015

Quantity

A) 69,008 Bottles, B) 399,730 Bottles, and C) 58,116 Bottles.

Recall type

Voluntary: Firm initiated

Recalling firm

Wockhardt Usa Inc.